Comparison of Echocardiographic Techniques in Diagnosis of Coronary Artery Disease - Tabular View

Tracking Information
First Received Date ^ICMJE	November 3, 1999
Last Updated Date	March 3, 2008
Start Date ^ICMJE	March 1999
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00001889 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Comparison of Echocardiographic Techniques in Diagnosis of Coronary Artery Disease
Official Title ^ICMJE	Comparison of Myocardial Contrast Echo With Dobutamine Echo in Diagnosis of Coronary Artery Disease
Brief Summary	This study is designed to compare two different echocardiographic techniques in the evaluation of heart disease (coronary artery disease). Both tests called Myocardial Contrast Echocardiography with Pharmacologic Stress and Stress Echocardiography with Dobutamine, are performed using a standard echocardiographic machine. Myocardial Contrast Echocardiography (MCE) does not use radioactivity. It uses sound waves like standard echocardiography. However, with MCE patients receive an injection of a "contrast agent" directly into the blood stream through a vein. The contrast agent, called Optison, is made of tiny microbubbles smaller than red blood cells. The echocardiogram can detect these microbubbles in the small blood vessels of the heart muscle and allow researchers to find areas of the heart receiving less blood flow than others. It is important to observe the heart during exercise because there are changes in blood flow. Since MCE cannot be performed when the patient is exercising, researchers give medication (adenosine) that stimulates the heart and creates a situation similar to exercise. Stress Echocardiography with Dobutamine does not use radioactivity. It uses sound waves like standard echocardiography. During this echocardiogram patients receive doses of a medication called dobutamine that stimulates the heart to beat stronger and faster. The purpose of this study is to evaluate the accuracy of MCE compared to stress echocardiography at detecting coronary artery disease (CAD).
Detailed Description	Stress echocardiography has become a valuable technique for the non-invasive detection of coronary artery disease (CAD). Its accuracy has been shown to be superior to that of the exercise electrocardiogram and comparable to that of myocardial perfusion imaging. Myocardial contrast echocardiography (MCE) offers the potential to evaluate tissue perfusion at the level where oxygen transfer to the myocytes occurs. MCE can, therefore, provide information regarding the functional status of the myocardial microvasculature and presence of blood flow disparity. The purpose of this study is to evaluate the accuracy of MCE compared to stress echocardiography. We will correlate these results with findings from coronary angiography and compare the ability of those techniques to detect CAD.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Safety/Efficacy Study
Condition ^ICMJE	Coronary Disease
Intervention ^ICMJE	Procedure: Myocardial contrast echocardiography Procedure: Stress echocardiography with dobutamine
Study Arms / Comparison Groups
Publications *	Lumley P, Broadley KJ, Levy GP. Analysis of the inotropic: chronotropic selectivity of dobutamine and dopamine in anaethetised dogs and guinea-pig isolated atria. Cardiovasc Res. 1977 Jan;11(1):17-25. Armstrong WF. Stress echocardiography for detection of coronary artery disease. Circulation. 1991 Sep;84(3 Suppl):I43-9. Pellikka PA. Stress echocardiography in the evaluation of chest pain and accuracy in the diagnosis of coronary artery disease. Prog Cardiovasc Dis. 1997 May-Jun;39(6):523-32. Review.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	150
Completion Date	March 2001
Primary Completion Date
Eligibility Criteria ^ICMJE	Patients with known or suspected coronary artery disease. Adults 18 years of age or older. No pre-menopausal patients who are lactating, pregnant or potentially pregnant as judged by history, physical examination, ultrasound or urine pregnancy test. No unstable angina patients. No recent myocardial infarction patients (less than 1 month). No frequent ectopy which precludes adequate image acquisition. No history of asthma or chronic obstructive pulmonary disease. No patients receiving aminophylline, theophylline or dipyridamole. No presence of second and third degree heart block without pacemaker. No significant hypertension (systolic blood pressure greater than 170 mm Hg) or hypotension (systolic blood pressure less than 100 mm Hg). No hypotension: basal sitting systolic arterial pressure less than 100 mm Hg confirmed 30 minutes later. No sinus tachycardia greater than or equal to 100 beats per min. No atrial fibrillation. No inadequate two-dimensional echocardiographic windows.
Gender	Both
Ages
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00001889
Responsible Party
Study ID Numbers ^ICMJE	990077, 99-H-0077
Study Sponsor ^ICMJE	National Heart, Lung, and Blood Institute (NHLBI)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	February 2000
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP